Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol

Alexander Thomas Cohen, Theodore Erich Spiro, Harry Roger Büller, Lloyd Haskell, Dayi Hu, Russell Hull, Alexandre Mebazaa, Geno Merli, Sebastian Schellong, Alex Spyropoulos, Victor Tapson, Alexander Thomas Cohen, Theodore Erich Spiro, Harry Roger Büller, Lloyd Haskell, Dayi Hu, Russell Hull, Alexandre Mebazaa, Geno Merli, Sebastian Schellong, Alex Spyropoulos, Victor Tapson

Abstract

Patients with acute medical illnesses are at increased risk of venous thromboembolism (VTE), a significant cause of morbidity and mortality. Thromboprophylaxis is recommended in these patients but questions remain regarding the optimal duration of therapy. The aim of this study is to determine whether oral rivaroxaban is non-inferior to standard-duration (approximately 10 days) subcutaneous (s.c.) enoxaparin for the prevention of VTE in acutely ill medical patients, and whether extended-duration (approximately 5 weeks) rivaroxaban is superior to standard-duration enoxaparin. Patients aged 40 years or older and hospitalized for various acute medical illnesses with risk factors for VTE randomly receive either s.c. enoxaparin 40 mg once daily (od) for 10 ± 4 days or oral rivaroxaban 10 mg od for 35 ± 4 days. The primary efficacy outcomes are the composite of asymptomatic proximal deep vein thrombosis (DVT), symptomatic DVT, symptomatic non-fatal pulmonary embolism (PE), and VTE-related death up to day 10 + 4 and up to day 35 + 4. The primary safety outcome is the composite of treatment-emergent major bleeding and clinically relevant non-major bleeding. As of July 2010, 8,101 patients from 52 countries have been randomized. These patients have a broad range of medical conditions: approximately one-third were diagnosed with acute heart failure, just under one-third were diagnosed with acute infectious disease, and just under one-quarter were diagnosed with acute respiratory insufficiency. MAGELLAN will determine the efficacy, safety, and pharmacological profile of oral rivaroxaban for the prevention of VTE in a diverse population of medically ill patients and the potential of extended-duration therapy to reduce incidence of VTE.

Figures

Fig. 1
Fig. 1
MAGELLAN study design. a Heart failure (New York Heart Association class III or IV), active cancer, acute ischemic stroke, acute infectious, acute inflammatory diseases or acute rheumatic diseases, or acute respiratory insufficiency. od once daily

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